Study Stopped
mid-term analysis
Decrease of Lesions Induced by Mechanical Ventilation During ARDS
ECMO-VILI
Reduction of Mechanical Ventilation-induced Lesions During ARDS With Multimodal Ultra-protective Ventilation in Combination With ECMO
2 other identifiers
interventional
38
1 country
1
Brief Summary
Modification of mechanically ventilated lesions by an ultra-protective multimodal strategy compared to a protective strategy in patients with veno-venous ECMO for severe ARDS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2019
CompletedFirst Posted
Study publicly available on registry
April 17, 2019
CompletedStudy Start
First participant enrolled
July 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 23, 2021
CompletedJuly 20, 2023
July 1, 2023
1.8 years
April 12, 2019
July 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
inflammation of biotrauma
Interleukine dosage in pg/mL
36months
Study Arms (2)
ultra-protective multimodal ventilation group
EXPERIMENTALPatient will be diposed on ventral decubitus: one session at least more than 12 hours between inclusion and H48
protective ventilation group
NO INTERVENTIONPatient will received usual care
Interventions
Patient will have one session at least more than 12 hours between inclusion and H48 of ventral décubitus
Eligibility Criteria
You may qualify if:
- severe ARDS with a PaO2 / FiO2 ratio ≤ 70 mmHg (for at least 2h) measured at PEEP\> 10 cmH2O and FiO2 = 1
- OR a severe ARDS with a PaO2 / FiO2\> 70 ratio but \<100 mmHg with a plateau pressure\> 35 cmH2O and a pH \<7.20
You may not qualify if:
- Patients with associated hemodynamic failure requiring veno-arterial ECMO
- Impossibility of setting up or contraindication to the placement of an esophageal tube
- Impossibility of realization of ventral decubitus
- Patient to receive corticosteroids during the first 48 hours following venous venous ECMO.
- Patients assisted by veno-venous ECMO for more than 24 hours.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique Hopitaux de Marseille
Marseille, 13354, France
Related Publications (1)
Guervilly C, Fournier T, Chommeloux J, Arnaud L, Pinglis C, Baumstarck K, Boucekine M, Valera S, Sanz C, Adda M, Bobot M, Daviet F, Gragueb-Chatti I, Forel JM, Roch A, Hraiech S, Dignat-George F, Schmidt M, Lacroix R, Papazian L. Ultra-lung-protective ventilation and biotrauma in severe ARDS patients on veno-venous extracorporeal membrane oxygenation: a randomized controlled study. Crit Care. 2022 Dec 12;26(1):383. doi: 10.1186/s13054-022-04272-x.
PMID: 36510324DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Emilie GARRIDO
Assistance Publique Hôpitaux de Marseille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2019
First Posted
April 17, 2019
Study Start
July 3, 2019
Primary Completion
April 23, 2021
Study Completion
June 23, 2021
Last Updated
July 20, 2023
Record last verified: 2023-07